By Oliver Wyrsch
In the light that the world is facing a persistent and increasing threat from counterfeit, misbranded, adulterated, or diverted prescription drugs, government leaders, politicians and executives from major pharmaceutical providers are driving efforts to develop methods to reliably track and trace prescription drugs.
Based on this growing threat, many countries have started to address vulnerabilities in the supply chain by enacting legislation which, among other things, requires a comprehensive system, most often referred to as serialization or in the United States as e-Pedigree (electronic pedigree).
This growing movement towards utilizing serialization to track drugs will inevitably lead to companies found to be receiving or sending unserialized drug shipments opening themselves up to fines, orders to discontinue operations or even criminal investigation.
The following pages provides companies, in accordance with current or emerging serialization legislation, critical information on making an implementation decision by:
- Summarizing the minimum requirements of a serialization solution
- Authentication and certification of each owner of a prescription drug from the current owner back to the original manufacturer
- Validation that serialization data matches the physical product received
- The means to check that all prescription drugs in stock have been serialised
- Association of serialization information when despatching products
- Confirmation that products have complete and accurate documentation
- Outlining the complexity involved when implementing a serialization solution
- Will existing national law need to be changed?
- Will serialization be required from all countries?
- Will there be a global standard?
- Detailed questions that must be addressed when choosing a production line equipment supplier
- How informed is the partner with current regulatory requirements? This is important to ensure required functionality is available in the solution and also ensures that the partner will be a valuable contributor in longer term strategic initiatives
- Is the partner able to supply solutions using tried and trusted components and technologies already in use in your production line? This will save considerable integration costs and time.
- Has the partner demonstrated the performance needed to meet the requirements?
- Does the partner have the financial stability and resources to meet near-term requirements and to deliver an economical service in the long-term?
- Does the partner have global service and support strategically located for rapid response when needed on site?
- Does the partner solutions have the flexibility to integrate your current software and hardware requirements including the ability to incorporate new features as technology and requirements evolve?
Most pharmaceutical companies have already started to focus on implementing a serialization strategy and defining their needs on trusted partners with production line serialization solutions. All pharmaceutical companies will be affected by serialization regulations. It is not an option to "wait and see" it's imperative to be a leader in the industry.
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